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United States · US · US:62207-891_44f30c29-5caf-7d3c-e063-6394a90a7d36

Fexofenadine Hydrochloride

Orange BookUNIISPLATC R06AX26

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGranules India Limited
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6220789149
    1000 TABLET, FILM COATED in 1 BOTTLE (62207-891-49)
  • ndc11
    6220789151
    1 BOTTLE in 1 CARTON (62207-891-51) / 10 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    6220789158
    7 BLISTER PACK in 1 CARTON (62207-891-58) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A211075
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2S068B75ZU",
    "rxcui": "236474",
    "inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
    "display_name": "FEXOFENADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52d50976-e63a-b3e3-e063-6294a90a6a97": {
      "match": "brand_token",
      "title": "FEXOFENADINE HCL TABLET [YYBA CORP]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "62207-891_44f30c29-5caf-7d3c-e063-6394a90a7d36",
  "productndc": "62207-891",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211075",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Oct 18, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Oct 18, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Fexofenadine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine Hydrochloride",
  "start_marketing_date": "20231107",
  "active_numerator_strength": "180"
}

Related drugs

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